MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) SUSTAIN XL DC; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	PM2134
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented for a pacemaker implant procedure.During the procedure, the physician could not feel the set screw on the pacemaker.The pacemaker was replaced during the procedure to resolve the issue.The patient was in stable condition throughout the procedure.
Additional Manufacturer Narrative
The reported event of could not engage or tighten the atrial setscrew was confirmed.Final analysis found the pacemaker was returned.The atrial setscrew was present in its normal position in the connector block of the pacer.The user of the torque wrench during the implant procedure made numerous off-center and angled incorrect wrench insertions through the septum such that the setscrew was never being properly engaged.The problem was caused by the user¿s incorrect use of the torque wrench.

• Brand Name: SUSTAIN XL DC
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15819013
• Report Number: 2017865-2022-45750
• Device Sequence Number: 15237161
• Product Code: NVZ
• UDI-Device Identifier: 05414734504720
• UDI-Public: 05414734504720
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: PM2134
• Device Catalogue Number: PM2134
• Device Lot Number: P000133490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2022
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown